BACKGROUND: The Merit Prelude Short Sheath Catheter Introducer is used to provide access and facilitate the introduction of other medical devices into veins or arteries while maintaining hemostasis for a variety of procedures.

RECOMMENDATION: Merit Medical Systems, Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: